The extension provisions for the Bangladesh Drug Administration (DGDA) certification of medical devices may vary depending on the specific circumstances, but in general, the extension provisions for certification may include the following:
Validity period of certification
First of all, after the company obtains the Bangladesh DGDA certification for medical devices, the certification certificate will indicate a validity period, usually one or two years.
Before the expiration of the certification period, enterprises need to prepare in advance and apply for an extension to ensure that the certification does not lapse after expiration.
Extension Application Procedure
Companies are required to submit an extension application to the DGDA before the certification expires, and the application process may require the relevant application** and application materials.
Extension applications usually need to state the reason and necessity of the extension, as well as provide relevant supporting documents or explanations.
Extension of the approval process
The DGDA will review the extension requests submitted by the company and re-evaluate the company's production practices, quality management system and product compliance.
If the certification body believes that the business still meets the certification requirements and the certification certificate has not expired, it will usually approve the extension application.
Extension Fees
Extension applications may be subject to an extension fee, the amount of which is usually determined by the certification body according to the actual situation and standard provisions.
Businesses are required to pay the extension fee on time and continue to meet the certification requirements after the extension is approved.
Extension of Validity
Once an extension is granted, the validity of the certification will be extended accordingly, usually for the same or similar period as the original certification.
The renewed certificate will be updated with the new expiration date and marked with the extension information of the certification.
Review and supervision
After the extension, the DGDA may strengthen the supervision and review of the company to ensure that the company continues to meet the certification requirements.
Including regular production site audits, quality management system audits, etc., to ensure that the quality and safety of products are continuously guaranteed.
In general, the extension provisions of the Bangladesh DGDA certification of medical devices involve the extension application process, approval process, fee payment, extension validity period, etc. Enterprises need to understand and comply with relevant regulations in a timely manner, and ensure that the extension procedures are completed before the expiration of the certification validity period to ensure the continued validity of the certification and the legal sales of products.